Modafinil
- Product NDC
- 42043-161
- 11-digit product format
- 420430161
- Labeler code
- 42043
- Product ID
- 42043-161_dc738068-3e56-47c5-afd8-7d471303c041
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OrchidPharma Inc
- Application
- ANDA078963
- Marketing category
- ANDA
- Marketing start
- 2013-08-01
- Marketing end
- 0000-00-00
- Substance
- MODAFINIL
- Active strength
- 200 mg/1
- Pharmacologic classes
- Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 91b7dea8-da1b-abb1-9750-2e680cd894b6 | Product name | 2 | 20171005 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42043-161-01 | 2024-12-23 | C162847 | 48780-1 | 0191ceaa-6229-198a-e063-dbdaa90aec3e | 01f6690c-1410-42ad-8eb3-e7df32eab3ba |
| 42043-161-03 | 2024-12-23 | C162847 | 48780-1 | 0191ceaa-6229-198a-e063-dbdaa90aec3e | 01f6690c-1410-42ad-8eb3-e7df32eab3ba |
| 42043-161-90 | 2024-12-23 | C162847 | 48780-1 | 0191ceaa-6229-198a-e063-dbdaa90aec3e | 01f6690c-1410-42ad-8eb3-e7df32eab3ba |
| 42043-161-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6229-198a-e063-dbdaa90aec3e | 01f6690c-1410-42ad-8eb3-e7df32eab3ba |
| 42043-161-03 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6229-198a-e063-dbdaa90aec3e | 01f6690c-1410-42ad-8eb3-e7df32eab3ba |
| 42043-161-90 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6229-198a-e063-dbdaa90aec3e | 01f6690c-1410-42ad-8eb3-e7df32eab3ba |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42043-161-01 | EA - Each | 42043-161 | 6cec15a7-3e25-4e5b-af2e-c823e24e6b66 | 1 | 2013-09-04 |
| 42043-161-03 | EA - Each | 42043-161 | 828ffb5f-dbb6-47a4-b3e9-2d045088e559 | 1 | 2013-09-04 |
| 42043-161-90 | EA - Each | 42043-161 | da45342e-adc6-4519-b0eb-e356106007ce | 1 | 2015-10-02 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 205324 | modafinil 200 MG Oral Tablet | PSN | 7e642144-a267-40b2-8684-a2cfbb7acc5f | 3 |
| 205324 | modafinil 200 MG Oral Tablet | SCD | 7e642144-a267-40b2-8684-a2cfbb7acc5f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42043-161-01 | 42043016101 | 1 BOTTLE, PLASTIC in 1 CARTON (42043-161-01) > 100 TABLET in 1 BOTTLE, PLASTIC | 2013-08-01 | 0000-00-00 | No | No | Current |
| 42043-161-03 | 42043016103 | 1 BOTTLE, PLASTIC in 1 CARTON (42043-161-03) > 30 TABLET in 1 BOTTLE, PLASTIC | 2013-08-01 | 0000-00-00 | No | No | Current |
| 42043-161-90 | 42043016190 | 1 BOTTLE, PLASTIC in 1 CARTON (42043-161-90) > 90 TABLET in 1 BOTTLE, PLASTIC | 2013-08-01 | 0000-00-00 | No | No | Current |